Ex Parte Nycz et al

Board of Patent Appeals and Interferences

Nov 17, 2011

11048064 (B.P.A.I. Nov. 17, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/048,064 02/02/2005 Jeffrey H. Nycz PC1017.00 2263
71998 7590 11/17/2011
Medtronic
Attn: Noreen Johnson - IP Legal Department
2600 Sofamor Danek Drive
Memphis, TN 38132
EXAMINER
WILSON, MICHAEL C
ART UNIT PAPER NUMBER
1632
MAIL DATE DELIVERY MODE
11/17/2011 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JEFFREY H. NYCZ and JON C. SERBOUSEK
__________

Appeal 2011-006654
Application 11/048,064
Technology Center 1600
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
methods of treating an osteolytic lesion. The Patent Examiner rejected the
claims for containing new matter and for obviousness. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse.

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STATEMENT OF THE CASE
Claims 31-36 and 52 are on appeal. Claim 35 is representative and
reads as follows:
35. A method of treating an osteolytic lesion comprising:
accessing the osteolytic lesion located at an interface between a
patient's bone and an orthopedic prosthetic by inserting a cannula or
guidewire through a passageway, wherein the osteolytic lesion is caused by
particulate induced bone resorption;
preparing the osteolytic lesion for receiving a bone growth promoting
substance by debriding a surface of the osteolytic lesion using a debriding
device; and
delivering the bone growth promoting substance to the osteolytic
lesion via a delivery apparatus selected from a cannula or graft syringe,
wherein the bone growth promoting substance is capable of adhering to the
osteolytic lesion and comprises: a carrier and at least one or more
osteoinductive agents selected from the group consisting of one or more
BMPs, one or more VEGFs, one or more CTGFs, osteoprotegerin, one or
more TGF-betas, and any combination thereof.

The Examiner rejected the claims as follows:
1

• claims 31-36 and 52 under 35 U.S.C. § 112, first paragraph, on the
grounds that “accessing the osteolytic lesion… by inserting a cannula or
guidewire through a passageway” is new matter; and
• claims 35 and 36 under 35 U.S.C. § 103(a) as unpatentable over
Tompkins,
2
Maloney,
3
or Lavernia,
4
in view of Wang
5
and Glowa;
6

1
The Examiner withdrew the rejection of claims 35, 36, and 41 under 35
U.S.C. § 103(a) as unpatentable over Tompkins, Maloney, or Lavernia, in
view of Wang, Glowa, and Petersen because claim 41 was cancelled. (Ans.
3-4.)
2
Geoffrey S. Tompkins, M.D., et al., Primary Total Hip Arthroplasty with a
Porous-Coated Acetabular Component, 79 J. OF BONE AND JOINT SURGERY
169-176 (1997).

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• claims 31, 32, 34, 35, and 36 under 35 U.S.C. § 103(a) as
unpatentable over Tompkins, Maloney, or Lavernia, in view of Wang and
Glowa, and further in view of Ferrara,
7
Aggarwal,
8
or Grotendorst;
9

• claims 33, 35, 36, and 52
10
under 35 U.S.C. § 103(a) as
unpatentable over Tompkins, Maloney, or Lavernia, in view of Wang,
Glowa, and Boyle.
11

CLAIM INTERPRETATION
Based on the arguments presented, the Examiner and Appellants have
differing opinions about whether the claimed methods limit accessing the
osteolytic lesion through a “minimally invasive technique.” Appellants

3
William J. Maloney, M.D., et al., Treatment of Pelvic Osteolysis
Associated with a Stable Acetabular Component Inserted without Cement as
Part of a Total Hip Replacement, 79 J. OF BONE AND JOINT SURGERY 1628-
1634 (1997).
4
Carlos J. Lavernia, M.D., et al., Arthroscopic Shaver-Assisted Total Hip
Arthroplasty Revision, 13 J. OF SURGICAL ORTHOPAEDIC ADVANCES 174-176
(2004).
5
Jeffrey C. Wang, M.D., et al., Effect of Regional Gene Therapy with Bone
Morphogenetic Protein-2-Producing Bone Marrow Cells on Spinal Fusion
in Rats, 85-A J. OF BONE AND JOINT SURGERY 905-911 (2003).
6
US Patent No. 5,779,697 issued to Michael P. Glowa et al., Jul. 14, 1998.
7
US Patent No. 6,455,283 B1 issued to Napoleone Ferrara et al., Sep. 24,
2002.
8
US Patent No. 6,998,383 B2 issued to Bharat Aggarwal et al., Feb. 14,
2006.
9
US Patent No. 5,837,258 issued to Gary R. Grotendorst, Nov. 17, 1998.
10
The Examiner “newly rejected” claim 52, stating “[i]t is obvious that
claim 52 was inadvertently omitted from the final rejection because all the
limitations in claim 52 (specifically osteoprotegerin) were addressed in the
body of the rejection.” (Ans. 4, 14.)
11
US Patent No. 6,015,938 issued to William J. Boyle et al., Jan. 18, 2000.
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assert that “it is clear that the claims have been limited to the preferred
embodiment described with reference to Figures 1 and 2 – a minimally
invasive technique,” i.e., “using a cannula or guidewire.” (App. Br. 3-4.)
The Examiner‟s position is that the claimed method step of accessing
the lesion is not limited to using minimally invasive techniques, but rather
may also include “conventional open surgical techniques.” (Ans. 2, 6.) In
particular, the Examiner‟s interpretation is that “the claims reasonably
encompass accessing an osteolytic lesion by inserting a cannula or guidewire
„through a passageway‟ [that is] made using „open procedures‟ or
„minimally invasive techniques.‟” (Id. at 3.)
Findings of Fact
1. The claims do not recite the phrase “minimally invasive procedure.”
2. The claims do not limit or otherwise recite how the “passageway”
through which the cannula or guidewire is inserted is created.
3. The Specification states that the bone defect can be accessed “using
conventional open surgical techniques” and also “by inserting a cannula 200
(or guidewire, not shown) through the skin 120 and soft tissue 130.” (Spec.
[0038]-[0039].)
4. The Specification states that “[i]n a preferred embodiment, accessing
the bone defect can be accomplished in any number of minimally invasive
methods known in the art ….” (Id. at [0039].)
5. The Specification does not explicitly state that accessing the osteolytic
lesion by inserting a cannula or guidewire through a passageway may not be
accomplished in a conventional open surgical technique.

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Principles of Law
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000). “Absent claim language carrying a
narrow meaning, the PTO should only limit the claim based on the
specification or prosecution history when those sources expressly disclaim
the broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004).
“[W]hile it is true that claims are to be interpreted in light of the
specification . . . , it does not follow that limitations from the specification
may be read into the claims . . . . It is the claims that measure the
invention.” Sjolund v. Musland, 847 F.2d 1573, 1581-82 (Fed. Cir. 1988)
(emphasis in original, citation omitted).
Discussion
We agree with Appellants that the Specification Figure 1 illustrates a
cannula inserted through the skin and soft tissue and that the Specification
states that “[t]he bone defect 100 can be accessed by inserting a cannula
200…or guidewire… through the skin 120 and soft tissue 130.” (App. Br.
3-4; FF-3.) We also agree that this technique may be considered one of the
preferred embodiments involving “minimally invasive methods” referred to
in the Specification. (FF-4.) However, unlike these statements in the
Specification, the claimed methods do not recite the phrase “minimally
invasive” methods, procedures or techniques. (FF-1.) Nor do the claimed
methods require inserting a cannula or guidewire “through the skin and soft
tissue.” Rather, the claims broadly recite that the osteolytic lesion is
accessed “by inserting a cannula or guidewire through a passageway.”
(Claim 35, emphasis added.) The claims do not recite any limitation as to
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the method, procedure or technique by which this “passageway” is created
(FF-2) and we do not read limitations from the Specification into the claims.
See Sjolund v. Musland, 847 F.2d at 1581-82. “It is the claims that measure
the invention.” Id. Therefore, we conclude that the claimed methods
encompass “inserting a cannula or guidewire through a passageway,”
wherein the passageway may be achieved using conventional open surgical
or minimally invasive techniques. See Bigio, 381 F.3d at 1325.
NEW MATTER
The Issue
The Examiner‟s position is that the Specification describes accessing
a bone defect “„using conventional open surgical techniques‟” and explains
that a preferred embodiment for accessing a bone defect is “minimally
invasive.” (Ans. 6.) The Examiner found that “„accessing the osteolytic
lesion…by inserting a cannula or guid[ewire] through a passageway‟” has a
different scope than accessing the lesion using conventional open surgical
techniques or by minimally invasive techniques. (Id.) According to the
Examiner, “[i]t is not readily apparent applicants contemplated the breadth
of accessing the osteolytic lesion by inserting a cannula or guidewire
through passageway as now claimed” because accessing a lesion in this
manner “is not implicit from the concept of accessing a bone defect using
conventional open surgical techniques… or by minimally invasive
techniques … as originally contemplated by applicants.” (Id.)
Appellants contend that the claims are fully supported by the
Specification, particularly paragraphs [0038]-[0040] which “refer[] to a
minimally invasive surgical procedure for accessing a bone defect by
inserting a cannula 200 or guidewire….” (App. Br. 11.)
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The issue is whether the Specification reasonably conveyed to a
person of ordinary skill in the art that the inventors had possession of
methods comprising accessing an osteolytic lesion by “inserting a cannula or
guidewire through a passageway.”
Findings of Fact
6. The Specification states that Figure 1 illustrates “a bone having a bone
defect, together with the adjacent tissue and a cannula inserted through the
tissue to a position adjacent the bone defect.” (Spec. [0016].)
7. The Specification states that Figure 2 illustrates “the bone and bone
defect of Figure 1 with the access apparatus [i.e., cannula] having dilated the
adjacent tissue to provide access to the bone defect.” (Id. at [0017].)
8. The Specification states that “[t]he bone defect 100 can be accessed
by inserting a cannula 200 (or guidewire, not shown) through the skin 120
and soft tissue 130.” (Id. at [0039].)
Principles of Law
The test for determining compliance with the written
description requirement is whether the disclosure of the
application as originally filed reasonable conveys to the artisan
that the inventor had possession at the time of the later claimed
subject matter, rather than the presence or absence of literal
support in the specification for the claim language.

In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983).
Analysis
We agree with Appellants that the Examiner has not established that
the claim phrase “inserting a cannula or guidewire through a passageway”
introduces new matter into the application disclosure. Rather, the
Specification as originally filed expressly disclosed this matter. (See FF-6,
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7, 8.) Thus, a skilled artisan would have understood that the inventors had
possession of the subject matter in question at the time the present
application was filed. See Kaslow, 707 F.2d at 1375. We reverse the new
matter rejection.

OBVIOUSNESS
The Issue
The Examiner‟s position is that Tompkins, Maloney and Lavernia
each taught a method of “treat[ing] osteolytic lesions at an interface between
a patient‟s bone and an orthopedic prosthetic by a) making an incision in the
skin and tissue, b) accessing the osteolytic lesion, c) debriding the surface of
the lesion, and d) delivering a bone graft.” (Ans. 7-8.) The Examiner found
that the “osteolytic lesions of Tompkins, Maloney and Lavernia were
implicitly accessed by creating a passageway through the patient‟s skin and
tissue as claimed because they were debrided and grafted.” (Id. at 8.)
According to the Examiner, “[t]he only way to debride and graft an
osteolytic lesion is by making a passageway th[r]ough the skin and tissue to
the osteolytic lesion.” (Id.)
Moreover, the Examiner found that the osteolytic lesions of Tompkins
and Maloney “were implicitly accessed using a cannula as claimed because
they were debrided and grafted.” (Id.) According to the Examiner,
“[d]ebriding must have required a tube for inserting the debriding
instrument, and grafting must have required some sort of tube for delivery of
the graft.” (Id.) Additionally, the Examiner found that Lavernia “implicitly
accessed” its osteolytic lesions “by arthroscopy which requires an
arthroscope which is equivalent to a cannula.” (Id.)
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Further, the Examiner found that “[i]f the osteolytic lesions of
Tompkins, Maloney and Lavernia were not accessed using a cannula as
claimed, arthroscopic cannulas were well known in the art at the time of
filing,” as evidenced by Glowa. (Id.) According to the Examiner,
“[a]ccessing osteolytic lesions with a cannula or guidewire was well within
the [purview] of those of ordinary skill in the art at the time of filing as
evidenced by Lavernia and Glowa.” (Id.)
Additionally, the Examiner found that “Tompkins, Maloney and
Lavernia did not teach deliver[ing] a polynucleotide encoding BMP, VEGF,
CTGF, osteoprotegerin, TGF-β, or a combination thereof to the lesion.” (Id.
at 9.) However, the Examiner found that Wang disclosed “deliver[ing] bone
marrow cells comprising adenovirus encoding BMP-2 with demineralized
bone matrix (DMB) or collagen sponge (Groups I and II) to a vertebrae of
the lumbar spine that had been decorticated using a speed burr.” (Id.) The
Examiner also found that the defect made by Wang was a lesion in the bone
and therefore modeled osteolysis at an interface between bone and an
orthopedic implant. (Id. at 10.)
According to the Examiner, it would have been obvious to a person of
ordinary skill in the art at the time the invention was made to treat an
osteolytic lesion at an interface between a patient‟s bone and an orthopedic
prosthetic comprising accessing the lesion using arthroscopy, as described
by Tompkins, Maloney and Lavernia, and further comprising delivering
bone marrow cells comprising adenovirus encoding BMP-2 to the osteolytic
lesion, as described by Wang. (Id.)
Regarding claims 31, 32, 34, 35, and 36, the Examiner further found
that the “combined teachings of Tompkins, Maloney, Lavernia, Wang and
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Glowa did not teach delivering CTGF, VEGF or TGF.” (Id. at 12.)
However, the Examiner found that treating bone defects with these growth
factors was known in the art at the time of the invention, as evidenced by
Ferrara, Aggarwal and Grotendorst. (Id.) According to the Examiner, a
skilled artisan would have been motivated to replace BMP-2 in the
combination with these growth factors because they were known to promote
bone tissue growth. (Id.)
Regarding claims 33, 35, 36 and 52, the Examiner further found that
the “combined teachings of Tompkins, Maloney, Lavernia, Wang and
Glowa did not teach delivering osteoprotegerin.” (Id. at 14.) However, the
Examiner found that treating bone defects with osteoprotegerin was known
in the art at the time of the invention, as evidenced by Boyle. (Id.)
According to the Examiner, a skilled artisan would have been motivated to
replace BMP-2 in the combination with osteoprotegerin because
osteoprotegerin was known to promote bone tissue growth. (Id.)
Appellants contend that Tompkins, Maloney and Lavernia did not
teach or suggest accessing the osteolytic lesion by “inserting a cannula or
guidewire through a passageway” as claimed. (App. Br. 16-18.) Further,
according to Appellants, each of these references taught away from doing so
because the disclosed surgical procedures involved replacing liners that
could not be performed using a cannula. (Id. at 16-17.)
The issue is whether the record supports the Examiner‟s finding that
Tompkins, Maloney and Lavernia each implicitly taught or suggested
accessing an osteolytic lesion by “inserting a cannula or guidewire through a
passageway,” or alternatively, the Examiner‟s conclusion that doing so
would have been obvious in view of Glowa.
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Findings of Fact
9. Tompkins described a hip that needed a reoperation for a problem
involving the acetabular component. (Tompkins 172.)
10. Tompkins described performing debridement and grafting of an area
of massive retroacetabular osteolysis. (Id.)
11. Maloney described “treat[ing] problems related to a porous-coated
acetabular component that had been inserted without cement during a total
hip arthroplasty” performed because pelvic osteolysis had developed.
(Maloney 1629.)
12. Maloney explained that the “revision consisted of exchange of the
polyethylene liner; débridement of the osteolytic lesion; and in some
patients, bone grafting.” (Id.)
13. Lavernia is a journal article entitled “Arthroscopic Shaver-Assisted
Total Hip Arthroplasty Revision” and describes a revision arthroplasty to
treat an osteolytic lesion on the left acetabular region in a patient who
previously had a hip replacement. (Lavernia 174.)
14. The Examiner found that Lavernia accessed the osteolytic lesion by
arthroscopy. (Ans. 7-8, citing Lavernia 174, paragraph bridging cols. 1-2.)
15. The paragraph of Lavernia that the Examiner cited does not explicitly
disclose accessing the osteolytic lesion by arthroscopy. (See Lavernia 174,
paragraph bridging cols. 1-2.)
16. The Examiner found that “[a]n arthroscopic shaver implicitly requires
arthroscopy, i.e. an arthroscope, i.e., a cannula or guidewire.” (Ans. 17.)
17. Glowa disclosed an arthroscopic cannula. (Glowa Abstract.)

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Principles of Law
The question of obviousness is resolved on the basis of underlying
factual determinations including (1) the scope and content of the prior art,
(2) any differences between the claimed subject matter and the prior art, (3)
the level of skill in the art, and (4) where in evidence, so-called secondary
considerations. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
A conclusion that the claimed subject matter is prima facie obvious
must be supported by evidence, as shown by some objective teaching in the
prior art or by knowledge generally available to one of ordinary skill in the
art that would have led that individual to arrive at the claimed invention.
See In re Fine, 837 F.2d 1071, 1074 (Fed. Cir. 1988).
Analysis
The claimed methods require “inserting a cannula or guidewire
through a passageway….” (See Claims 35 and 52.) We agree with the
Examiner (Ans. 8) that Tompkins and Maloney each described debriding
and grafting an osteolytic lesion (see FF-10, 12.) For each of the rejections,
the Examiner further finds that Tompkins and Maloney “implicitly”
accessed the osteolytic lesion by using a cannula. (Ans. 8.) According to
the Examiner, “[d]ebriding must have required a tube for inserting the
debriding instrument, and grafting must have required some sort of tube for
delivery of the graft.” (Id.) However, this reasoning is speculative and
unsupported by the record evidence. Consequently, we agree with
Appellants (App. Br. 15) that the Examiner has not properly determined “the
scope and content” of Tompkins and Maloney, as required to resolve a
question of obviousness. See Graham v. John Deere Co., 383 U.S. at 17.
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Additionally, for each of the rejections, the Examiner found that
Lavernia “implicitly” accessed the osteolytic lesion by using a cannula
“because Lavernia specifically [taught that] the lesions were accessed by
arthroscopy which requires an arthroscope which is equivalent to a cannula.”
(Ans. 8.) Appellants acknowledge that Lavernia inserted an arthroscopic
shaver through holes drilled in the acetabular cup, but contend Lavernia used
an “open procedure,” which their method does not. (App. Br. 17.) That
argument is unpersuasive because “open” procedures are not disclaimed and
because there is no significant difference between inserting the arthroscopic
device through a drilled hole and the claimed method of inserting a device
through a passageway. More persuasive are Appellants‟ contentions
concerning the difference between Lavernia‟s shaver and the cannula or
guidewire used in the claimed method. The Examiner found that Lavernia
accessed the osteolytic lesion by arthroscopy, but the paragraph of Lavernia
that the Examiner cited does not disclose accessing the osteolytic lesion by
arthroscopy. (FF-14, 15.) Therefore, the Examiner‟s finding is not
supported by explicit evidence. The Examiner argues that “[a]n arthroscopic
shaver implicitly requires arthroscopy, i.e., an arthroscope, i.e., a cannula or
guidewire” (FF-16), but the Examiner provides no evidence to support this
disputed finding. Thus, the Examiner‟s reasoning is again speculative and
unsupported by the record evidence. Consequently, we agree with
Appellants (App. Br. 15) that the Examiner has also not properly determined
“the scope and content” of Lavernia, as required to resolve a question of
obviousness. See Graham v. John Deere Co., 383 U.S. at 17.
Alternatively, the Examiner found that “[i]f the osteolytic lesions of
Tompkins, Maloney and Lavernia were not accessed using a cannula as
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claimed, arthroscopic cannulas were well known in the art,” as evidenced by
Glowa. (Ans. 8.) According to the Examiner, “[a]ccessing osteolytic
lesions with a cannula or guidewire was well within the [purview] of those
of ordinary skill in the art at the time of filing as evidenced by Lavernia and
Glowa.” (Id.) We agree with the Examiner that Glowa provides evidence
that arthroscopic cannulas were well known in the art at the time of the
invention. (FF-17.) However, the Examiner has not established that
Lavernia‟s shaver and/or Glowa‟s disclosure suggested using cannulas to
access osteolytic lesions, nor has the Examiner provided any additional
evidence that such use would have been obvious to the skilled artisan at the
time of the invention. See Fine, 837 F.2d at 1074.
Accordingly, we reverse the obviousness rejections.

CONCLUSIONS OF LAW
The Specification reasonably conveyed to a person of ordinary skill in
the art that the inventors had possession of methods comprising accessing an
osteolytic lesion by “inserting a cannula or guidewire through a
passageway.”
The record does not support the Examiner‟s finding that Tompkins,
Maloney and Lavernia each implicitly taught or suggested accessing an
osteolytic lesion by “inserting a cannula or guidewire through a
passageway,” and the record does not support the Examiner‟s conclusion
that doing so would have been obvious in view of Glowa.

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SUMMARY
We reverse the rejection of claims 31-36 and 52 under 35 U.S.C.
§ 112, first paragraph, on the grounds that “accessing the osteolytic lesion…
by inserting a cannula or guidewire through a passageway” is new matter;
we reverse the rejection of claims 35 and 36 under 35 U.S.C. § 103(a)
as unpatentable over Tompkins, Maloney, or Lavernia, in view of Wang and
Glowa;
we reverse the rejection of claims 31, 32, 34, 35, and 36 under
35 U.S.C. § 103(a) as unpatentable over Tompkins, Maloney, or Lavernia, in
view of Wang, Glowa, Ferrara, Aggarwal, and Grotendorst; and
we reverse the rejection of claims 33, 35, 36, and 52 under 35 U.S.C.
§ 103(a) as unpatentable over Tompkins, Maloney, or Lavernia, in view of
Wang, Glowa, and Boyle.

REVERSED

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